Growth and Tolerance of Infants Fed Milk-Based Infant Formula

Completed · Not applicable

Conditions studied: Gastro-Intestinal Tolerance

In brief

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Key facts

Study ID

NCT03967132

Run by

Abbott Nutrition

People needed

189

Starts

2019-06-08

Expected to finish

2020-05-29

Last updated by the study team

2020-09-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good health as determined from participant's medical history
• Singleton from a full-term birth with a gestational age of 37-42 weeks
• Birth weight was > 2490 g (\~5 lbs. 8 oz.)
• If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
• If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

You may not qualify if…

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study by AN.

Where it is running

• Watching Over Mothers & Babies — Tucson, Arizona, United States
• Pediatric Medical Associates — Sacramento, California, United States
• Norwich Pediatric Group, P.C. — Norwich, Connecticut, United States
• Phoenix Medical Research LLC — Miami, Florida, United States
• University Clinical Research-Deland, LLC a/b/a Accel Clinical Research — Orlando, Florida, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Michael W. Simon, M.D., PSC — Nicholasville, Kentucky, United States
• Springs Medical Research — Owensboro, Kentucky, United States
• Institute of Clinical Research, LLC — Mentor, Ohio, United States
• The Cleveland Pediatric Research Center, LLC — Middleburg Heights, Ohio, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Midsouth Center for Clinical Research — Memphis, Tennessee, United States
• ARC Clinical Research at Wilson Parke — Austin, Texas, United States
• Ventavia Research Group, LLC — Fort Worth, Texas, United States
• Ventavia Research Group — Houston, Texas, United States
• Ventavia Research Group, LLC 3078 — Keller, Texas, United States
• Kagan Pediatrics - HD Research Corporation — Pearland, Texas, United States
• Plano Pediatrics - ACRC Trials — Plano, Texas, United States

Full record on ClinicalTrials.gov

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